IBU
- Product NDC
- 70934-195
- 11-digit product format
- 709340195
- Labeler code
- 70934
- Product ID
- 70934-195_b8e2559d-3cd6-0f22-e053-2a95a90a519e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2018-11-29
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70934-195 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70934-195 | 70934-195-30 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70934-195-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70934-195-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70934-195-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70934-195-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70934-195-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70934-195-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70934-195-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70934-195-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70934-195-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70934-195-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70934-195-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70934-195-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075682-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | |
| A075682-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | |
| A075682-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075682-001 | AB |
| A075682-002 | AB |
| A075682-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075682-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075682-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-195-30 | 2021-01-31 | C162847 | 48780-1 | ba0f9c33-4365-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
| 70934-195-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4365-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals, Inc. | 72ec2491-924d-460f-9510-62d624d54b59 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Golden State Medical Supply, Inc. | bbf4821d-f9fc-9f6e-e053-2a95a90a5253 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 4522b794-5c93-44cd-e063-6394a90ab39a | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 45223597-0ea8-b275-e063-6394a90a8412 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 4522cb9e-4999-c455-e063-6294a90a294f | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Proficient Rx LP | a7098fa1-b5ae-485e-ada9-64154f81fb6a | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Golden State Medical Supply, Inc. | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Major Pharmaceuticals | ba86e936-ef72-43e5-aebf-f2c788fe2266 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Cardinal Health 107, LLC | 8ea0e303-3967-4d71-8255-ac42a841ce28 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Dr. Reddy's Laboratories Limited | 24731405-219c-79b4-ecf0-7d5fbfda94ba | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBU | RedPharm Drug, Inc. | 4db219dc-ea48-490c-e054-00144ff88e88 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 31e6005b-492e-7936-e063-6394a90ad801 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 31e6ac7a-fa3e-4dd4-e063-6294a90a29af | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 7650f84b-92f2-4065-8ef2-f5de5bd7002b | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 593d9870-0213-75e6-e053-2991aa0a0eff | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | NuCare Pharmaceuticals Inc. | 575c275c-3e1a-0572-e053-2991aa0adabd | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 678e2d16-33f3-67a7-e053-2991aa0a1132 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Proficient Rx LP | ea6f626d-cda3-46e2-9ac9-4e72204cb726 | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | b0f03994-b744-4d66-95b7-8c86217882bc | 2021-05-24 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd | 2021-01-21 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-195-30 | 70934019530 | 30 TABLET in 1 BOTTLE, PLASTIC (70934-195-30) | 30 tablet | 2018-11-29 | 0000-00-00 | No | No | Current |